# C_2010346EN.01000501.xml

| 18.12.2010 | EN | Official Journal of the European Union | C 346/5 |
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18.12.2010

EN

Official Journal of the European Union

C 346/5

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Judgment of the Court (First Chamber) of 28 October 2010 — European Commission v Republic of Lithuania

(Case C-350/08) (1)

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(Failure of a Member State to fulfil obligations - 2003 Act of Accession - Obligations of the accession States - Acquis communautaire - Directives 2001/83/EC and 2003/63/EC - Regulation (EEC) No 2309/93 and Regulation (EC) No 726/2004 - Medicinal products for human use - Similar biological medicinal products from biotechnical processes - National marketing authorisation granted before accession)

2010/C 346/07

Language of the case: Lithuanian

Parties

Parties

Applicant: European Commission (represented by: A. Steiblytė and M. Šimerdová, acting as Agents)

Applicant:

Defendant: Republic of Lithuania (represented by: D. Kriaučiūnas and R. Mackevičienė, acting as Agents)

Defendant:

Re:

Re:

Failure of a Member State to fulfil obligations — Breach of Article 6(1) of and Section 4 of Part II of Annex I to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), as amended by Directive 2003/63/EC, and of Article 3(1) of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ 1993 L 214, p. 1) and Article 3(1) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1) — Maintenance of the national marketing authorisation for the similar biological medicinal product ‘Grasalva’

Operative part of the judgment

Operative part of the judgment

The Court:

| 1. | Declares that, by maintaining in force the national marketing authorisation for the medicinal product Grasalva, the Republic of Lithuania has failed to fulfil its obligations under Article 6(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Commission Directive 2003/63/EC of 25 June 2003, under Article 3(1) of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, and under Article 3(1) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency; |
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1.

Declares that, by maintaining in force the national marketing authorisation for the medicinal product Grasalva, the Republic of Lithuania has failed to fulfil its obligations under Article 6(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Commission Directive 2003/63/EC of 25 June 2003, under Article 3(1) of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, and under Article 3(1) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;

| 2. | Orders the Republic of Lithuania to pay the costs. |
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2.

Orders the Republic of Lithuania to pay the costs.

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(1)  OJ C 247, 27.9.2008.

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